- Topics
- Form 1572
- 21 CFR 312.50
- What is FDA form 1572?
- Statement of Investigator
- When don’t we use the 1572?
- Investigation Device Studies
- Non-IND Studies
- Why does the Investigator need to fill it out?
- Dual Purpose
- FDA Form 1572 and FAQs
- Guidance for sponsors, investigators and IRBs
- 1572 Commitments
- When to sign the 1572?
- The “Legal” Part
- 1572 Commitments
- Statement of Investigator
- Binding Agreement
- Helpful Reference!
- 21 CFR 312.50
- General responsibilities of sponsors
Nancy Pire-Smerkanich, DRSc, MS
Associate Director, Regulatory Knowledge and Support